Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 13, 2013
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for t
Alcohol Prep Pads contained within the kit are not properly labeled.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Insulet Corporation recalled OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490… - a moderate-severity action.
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490… was recalled by Insulet Corporation in November 13, 2013. Reason: Alcohol Prep Pads contained within the kit are not properly labeled.. Check the official notice for the remedy. Verify recall #Z-0166-2014 with the FDA Devices before acting.
The recall
Insulet Corporation issued this moderate-severity FDA Devices recall-Alcohol Prep Pads contained within the kit are not properly labeled..
- Moderate
- severity level
- Class II
- classification
- November 13, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0166-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0166-2014) was formally reported on November 13, 2013, with the manufacturer initiating the action on September 27, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Insulet Corporation is listed as the recalling firm, operating out of Bedford, MA. Federal records list the affected scope as 5,050 kits.
The documented reason for this recall is: Alcohol Prep Pads contained within the kit are not properly labeled. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and the country of Israel.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,050 kits
Related Recalls
6
3 from same agency
Product description
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.
Reason for recall
Alcohol Prep Pads contained within the kit are not properly labeled.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0166-2014 |
| Date reported | November 13, 2013 |
| Date initiated | September 27, 2013 |
| Recalling firm | Insulet Corporation |
| Firm location | Bedford, MA |
| Affected scope | 5,050 kits |
| Distribution | Worldwide Distribution - USA Nationwide and the country of Israel. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0166-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.. Recalled by Insulet Corporation. Units affected: 5,050 kits.
Why was this product recalled? ▼
Alcohol Prep Pads contained within the kit are not properly labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2013. Severity: Moderate. Recall number: Z-0166-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide and the country of Israel..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0166-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 13, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.